Trial of pIL-12 Electroporation Malignant Melanoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overPharmaceutical / IndustryOMS-I100
11854, NCT01502293

Trial Description

Summary

This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12 DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12 EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.

Eligibility Criteria

Inclusion Criteria:

  • Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma
  • Age ≥ 18 years of age
  • ECOG performance status 0-2
  • Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon, ipilimumab, or IL-2) with progression or persistent disease
  • Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field
  • Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug
  • Adequate organ function
  • Able to give informed consent

Exclusion Criteria:

  • Prior therapy with IL-12 or prior gene therapy
  • Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of subject participation on study
  • Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study enrollment
  • Pregnant or breast-feeding women
  • Patients with electronic pacemakers or defibrillators are excluded from this study
  • The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition (patients with thyroiditis are eligible)
  • Life expectancy of less than 6 months
  • History of significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias)
  • Other clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active CNS disease, active infection or any other condition that could compromise the patients participation in the study according to the investigator

Trial Contact Information

Trial Lead Organizations/Sponsors

OncoSec Medical Incorporated

    Mai H Le, M.D., Study Director
    Mai H Le, M.D.
    Ph: 858-255-4729
    Email: investors@oncosec.com

    Trial Sites

    U.S.A.

    California
    San Francisco

    UCSF Helen Diller Family Comprehensive Cancer Center

    Adele Hobbs Muthukumar
    Ph: 415-514-6427
    Email: Adele.Hobbs@ucsf.edu

    Adil Daud
    Sub-Investigator

    Alain Algazi, MD
    Principal Investigator

    Pennsylvania
    Bethlehem

    St. Luke's University Health Network

    Robyn Rex, RN, OCN, CCRP
    Ph: 484-503-4152
    Email: robyn.rex@sluhn.org

    Sanjiv S Agarwala, MD
    Principal Investigator

    Washington
    Seattle

    Seattle Cancer Care Alliance /University of Washington Cancer Consortium

    Nichole Real
    Ph: 206-288-7476
    Email: nreal@seattlecca.org

    Shailender Bhatia, MD
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01502293
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.